TM "Rehabilitimed" OT-1V-U L Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" OT-1V-U L Comfort
• Primary DI: 04823097722350
• Version / Model: OT-1V-U L Comfort
• Catalog Number: OT-1V-U L Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-17
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: 11dce1c3-5237-4610-ad3b-93f82c155185

Device Description

Semi-rigid beige posture corrector, used for strong fixation of the spine. Stabilizes the spine due to 4 metal stiffening ribs and strengthens the abdominal muscle wall using the compression effect of the elastic bandage fabric. Made of durable elastic bandage fabric made of polyamide and elastane and multilayer material with a cotton layer to the body and polyamide on the outside.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPT	Orthosis, Thoracic	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41042	Thoracic spine orthosis	A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097722350	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Hip circumference below the waistline by 4 inches(inch): 38-42